Method of using, and determining location of, an ingestible capsule

ABSTRACT

The present invention broadly provides an improved ingestible capsule ( 28 ) that is arranged to sense one or more physiological parameters within a mammalian body, an to transmit such parameters to an extra-corporeal receiver ( 50 ). In use, the capsule and receiver perform the method of determining the real-time location of the capsule within a tract of a mammal. This method includes the steps of providing the capsule, the capsule having one or more sensors, ingesting the capsule, transmitting a signal from the capsule, receiving the transmitted signal, and determining the real-time location of the capsule within the tract as a function of the received signal. The received signal may also indicate the value of one or more sensed parameters.

CROSS-REFERENCE TO RELATED APPLICATION

[0001] The present application claims the benefit of the earlier filingdate of Provisional Patent Application Serial No. 60/370,540, filed Apr.8, 2002.

TECHNICAL FIELD

[0002] The present invention relates generally to the field of capsulesthat are adapted to be ingested, inserted, implanted or otherwisepositioned in a mammalian body or tract to sense and determine one ormore physiological parameters of the body or tract, and to communicatesuch sensed parameters via one or more tissue-penetrating signals to anextra-tract or extra-corporeal receiver.

BACKGROUND ART

[0003] The ever-advancing field of medical science continuously seeksnew and improved diagnostic tools.

[0004] In early years, the diagnostic tools were largely represented byoutward physical manifestations, such as blood pressure, temperature,chills, and the like. These manifestations were conditions andparameters that could be simply observed or measured from outside thebody.

[0005] In more recent times, certain tools, such as endoscopes, havebeen developed that allow penetration of certain body tracts andcavities in an attempted to gather additional diagnostic data. Forexample, it is common today to use an endoscope-like device for acolonoscopy or sigmoidoscopy, to visually inspect the lowergastrointestinal tract. Endoscopes are also used to inspect othermammalian cavities. For example, in veterinary science, endoscopes arecommonly used to inspect nasal cavities of horses and other animals.

[0006] There are a number of tracts in a mammalian body. These includethe gastrointestinal tract, which extends from mouth to anus, thereproductive tract, the auditory tract, and the respiratory tract.

[0007] Considering a mammalian gastrointestinal tract for the moment,there is a large amount of physiological data that is potentiallyavailable within such tract. This data could include sensed parameters,such as pH, pressure, temperature, transit time, the presence or absenceof a disease marker, the presence or absence of some other diagnosticmarker, the presence or absence of an antibody or antigen, subsurfaceimaging, conductance, or even an electrical signal. In addition, it maybe desirable to topically apply medicaments to a particular situs withinsuch a tract, or, alternatively, to take a fluid sample at a selectedlocation within such tract.

[0008] To this end, various radio telemetry capsules have beendeveloped. Basically, these are small pill-like devices that can beingested or swallowed by a patient. The capsule may have a sensor todetermine a physiological parameter of the gastrointestinal tract. Somedevices contemplate that the parameter be sensed and transmitted by anRF signal to an extra-corporeal antenna or receiver. For example, U.S.Pat. No. 3,739,279 appears to disclose an oscillator circuit for such aningestible capsule. This patent then discloses a type of Colpittsoscillator which may be used in association with a telemetry sensor fordetermining physiological information within the patient's body. Thispatent recites that earlier telemetry systems have been developed fortransmitting information such as temperature, pressure, specific ionactivity, pH, pK and the like via an ingestible radio capsule.

[0009] Others have attempted to develop ingestible capsules that can beused to transmit a video signal to a location outside the body.References teaching this concept are shown and described in U.S. Pat.No. 6,240,312, B12 and in an internet article “Capsule Endoscopy GetsMap, Compass”,http://www.gastroendonews.com/cgi-bin/wwread.pl?cat.=gastro&art=gen0802-01a.htm(Aug. 27, 2002). Still another reference is an article by Brad Lemly,“Ted Med”, Discover (April 2003) [at pp. 70 et seq.]. This article evenhas a photograph of an ingestible video capsule manufactured by GivenImaging.

[0010] Other references for measuring temperature are provided in U.S.Pat. Nos. 4,844,076 and 4,689,621.

[0011] Other references have been directed toward dispensation ofmedicaments at selected sites within the gastrointestinal tract. See,e.g. U.S. Pat. Nos. 4,425,117, and 6,245,057.

[0012] Still another report on such ingestible capsules, appears inMilner, “Advances In and Prospects for Bio-Telemetry”, symposium onBio-Telemetry (Pretoria 1971).

[0013] Still another reference appears in an article by AlexandraStrikeman, “The Programmable Pill”, Technology Review (M.I.T. May 22,2001) [also available athttp://www.technologyreview.com/magazine/may01/strikeman.asp].

[0014] Therefore, it is clear that others have attempted to developingestible pills or capsules for sensing and determining variousphysiological parameters, and broadcasting them via an RF signal to anextra-corporeal receiver.

[0015] However, the values of such sensed parameters may not besufficient in and of themselves. Indeed, it is also important to knowthe location of the pill at the time the physiological parameter issensed. To this end, U.S. Pat. No. 5,279,607 discloses an ingestibletelemetry capsule with a means to determine location of the capsule. The'607 patent also discloses the capsule as having a medicament dispensingfunction. Thus, according to this patent, a capsule may be ingested tomap the gastrointestinal tract. Thereafter, another capsule, this onecontaining a medicament, may be ingested. This capsule may be caused todispense its medicament at a desired location within the body.

[0016] U.S. Pat. No. 5,395,366, discloses a concept related to the '607patent. However, according to this device, a fluid sample may be takeninto a compartment in an ingestible capsule at a selected locationwithin the body.

[0017] While these devices, taken individually and collectively, showthe state of, and advances in, the art, it is believed that it is nowpossible to determine the current or real-time location of a capsulewithin a tract in a mammalian body. It is also believed that thisimproved location-sensing method, may be used together withcorroborative data provided by the sensors themselves to verify thelocation within the body.

DISCLOSURE OF THE INVENTION

[0018] With parenthetical reference to the corresponding parts, portionsor surfaces of the disclosed embodiments, merely for purposes ofillustration and not by way of limitation, the present invention broadlyprovides an improved method of using, and determining the real-timelocation of, an capsule that is adapted to be ingested, inserted,implanted or otherwise positioned within a mammalian body or tract.

[0019] As used herein, the expression “real-time location” means thelocation of the capsule at the time a signal is transmitted from thecapsule to an extra-tract or extra-corporeal receiver, regardless ofwhether the signal is read contemporaneously when received, or recordedand stored for subsequent reading or analysis.

[0020] In one aspect, the invention provides an improved method ofdetermining the real-time location of a capsule (28) in a tract of amammal, comprising the steps of: providing a capsule, the capsule havingsensors (29, 30, 31, 33, 34) to determine at least two physiologicalparameters of the tract, the capsule also having a transmitter (39)operatively arranged to transmit a signal reflecting such sensedparameters; inserting the capsule into the tract; transmitting thesignal from the transmitter; receiving the transmitted signal exteriorly(at 41) of the tract; and determining the real-time location of thecapsule within the tract as a function of the received signal.

[0021] In another aspect, the invention provides an improved method ofdetermining the real-time location of a capsule in a tract of a mammal,comprising the steps of: providing a capsule, the capsule having atleast one sensor operatively arranged to determine a physiologicalparameter of the tract, the capsule also having a transmitter; insertingthe capsule into the tract; transmitting from the transmitter a signalreflective of the value the sensed parameter; receiving the transmittedsignal exteriorly of the tract; and determining the real-time locationof the capsule within the tract as a function of the received signal andthe received value of the sensed parameter.

[0022] In another aspect, the invention provides an improved method ofdetermining the value of a physiological parameter in a tract of amammal, comprising the steps of: providing an MRI-compatible capsule,the capsule having a sensor operatively arranged to determine at leastone physiological parameter of the tract, the capsule also having atransmitter operatively arranged to transmit a signal reflecting suchsensed parameter; inserting the capsule into the tract; tethering thecapsule to an object; transmitting the signal from the transmitter;receiving the transmitted signal exteriorly of the tract; anddetermining the value of the sensed parameter as a function of thereceived signal.

[0023] In the foregoing methods, the signal may be a radio signal and/oran acoustic signal. The tract may be an auditory, respiratory,reproductive and a gastrointestinal tract. The capsule may be insertedor ingested into the gastrointestinal tract. The location of the capsulemay be determined as a function of the phase difference between thetransmitted and received signals, or as a function of the difference intime between the time of transmission of the transmitted signal and thetime of receipt of the received signal. The method may include theadditional step of determining the value of at least one of the sensedparameters exteriorly of the tract as a function of the received signal.

[0024] Alternatively, the real-time location of the capsule within thetract may be determined as a function of the strength of the receivedsignal and such received value of at least one of the sensed parameters.

[0025] The capsule may be tethered to an object, such as another capsulethat is inserted into the tract, or to an object located outside thebody.

[0026] The capsule may have a storage compartment containing medicament,and the method may include the additional step of dispensing medicamentfrom the compartment at a desired location within the tract.Alternatively, the capsule may have a fluid storage compartment, and themethod may include the additional step of taking in a fluid sample tothe compartment at a desired location within the tract. At least one ofthe sensors may be arranged within the fluid storage compartment.

[0027] In one form, the capsule may have sensors to determine at leasttwo of the physiological parameters, wherein some of the sensedparameters are used to determine a first location of the capsule,wherein others of the sensed parameters are used to determine a secondlocation of the capsule, and wherein the first and second locations arecompared to corroborate the location of the capsule.

[0028] The sensed physiological parameters may be selected from thegroup consisting of: pH, pressure, temperature, transit time, a diseasemarker, a diagnostic marker, an antibody, an antigen, subsurface imaging(e.g., fluorescence or optical imaging), conductance, and an electricalsignal.

[0029] In another aspect, the invention provides an improved method ofdetermining the real-time location of a capsule in a tract of a mammal,comprising the steps of: providing a capsule, the capsule also having atransmitter operatively arranged to transmit an RF signal, eithercontinuously or intermittently, at a frequency in excess of about 5kilohertz; inserting the capsule into the tract; transmitting the signalfrom the transmitter; receiving the transmitted signal exteriorly of thetract; and determining the real-time location of the capsule within thetract as a function of the received signal. In this aspect, thetransmitter may be operatively arranged to transmit a signal a frequencyof less that about 10 gigahertz.

[0030] In another aspect, the invention provides an improved method ofdetermining the real-time location of a capsule in a tract of a mammal,comprising the steps of: providing a capsule, the capsule also having atransmitter operatively arranged to transmit an acoustic signal at afrequency in excess of about 100 hertz; inserting the capsule into thetract; transmitting the signal from the transmitter; receiving thetransmitted signal exteriorly of the tract; and determining thereal-time location of the capsule within the tract as a function of thereceived signal. In this aspect, the transmitter may be operativelyarranged to transmit a signal, either continuously or intermittently, afrequency of less that about 1.5 megahertz.

[0031] In another aspect, the invention provides an improved method ofdetermining the real-time location of a capsule in a tract of a mammal,comprising the steps of: providing a capsule, the capsule having atransmitter operatively arranged to transmit a signal; inserting thecapsule into the tract; providing a plurality of receivers exteriorly ofthe tract; transmitting the signal from the transmitter; receiving thetransmitted signal on the receivers; and determining the real-timelocation of the capsule as a function of the signals received by thereceivers. The capsule may have at least one sensor operatively arrangedto determine at least one physiological parameter within the tract, andthe transmitter may be arranged to generate a signal reflective of suchsensed parameter. The real-time location of the capsule may bedetermined using algorithm-based logic, such as artificial intelligence,a neural net, or a determinative statistical approach.

[0032] In still another aspect, the invention provides an improvedmethod of determining the value of a parameter in a mammal body,comprising the steps of: providing a capsule, the capsule having asensor to determine a physiological parameter of the body and having atransmitter operatively arranged to transmit a signal; inserting thecapsule into the body; providing a receiver exteriorly of the body;transmitting the signal from the transmitter; receiving the transmittedsignal on the receiver; and determining the value of the physiologicalparameter exteriorly of the body as a function of the signals receivedby the receiver. In this aspect, the capsule may be stationary withinthe body.

[0033] Accordingly, the general object is to provide an improved methodof determining the real-time location of a capsule within a tract of amammalian body.

[0034] Another object is to provide a method of determining at least onephysiological parameter within a mammalian body and the real-timelocation of the place from which that parameter was taken.

[0035] These and other objects and advantages will become apparent fromthe foregoing and ongoing written specification, the drawings and theappended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

[0036]FIG. 1 is a schematic view of a single-sensor capsule.

[0037]FIG. 2 is a schematic view of a multi-sensor capsule.

[0038]FIG. 3 is a schematic view of a medicament-dispensing capsule.

[0039]FIG. 4 is a schematic view of a fluid-sampling capsule.

[0040]FIG. 5 is a schematic view of the receiving circuitry for thecapsule shown in FIGS. 1 and/or 2.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0041] At the outset, it should be clearly understood that likereference numerals are intended to identify the same structuralelements, portions or surfaces consistently throughout the severaldrawing figures, as such elements, portions or surfaces may be furtherdescribed or explained by the entire written specification, of whichthis detailed description is an integral part. Unless otherwiseindicated, the drawings are intended to be read (e.g., cross-hatching,arrangement of parts, proportion, degree, etc.) together with thespecification, and are to be considered a portion of the entire writtendescription of this invention. As used in the following description, theterms “horizontal”, “vertical”, “left”, “right”, “up” and “down”, aswell as adjectival and adverbial derivatives thereof (e.g.,“horizontally”, “rightwardly”, “upwardly”, etc.), simply refer to theorientation of the illustrated structure as the particular drawingfigure faces the reader. Similarly, the terms “inwardly” and “outwardly”generally refer to the orientation of a surface relative to its axis ofelongation, or axis of rotation, as appropriate.

[0042] Referring now to the drawings, and more particularly to FIG. 1thereof, an improved single-sensor ingestible capsule is generallyindicated at 20. Capsule 20 is shown as being an elongatedellipsoid-shaped device, somewhat resembling a medicament capsule. Theenclosed drawing is not to scale, but, rather, is schematic. Sensor 20is shown as broadly including a pressure sensor 21, a non-cloggingpressure port 22, a compartment containing transmitting electronics 23,a battery compartment 24, a transmitting antenna, schematicallyindicated at 25, and a power switch and seal, generally indicated at 26.In the schematic view of FIG. 1, antenna 25 is shown as extendingupwardly and away from the body of the capsule. However, this is onlyfor schematic purposes. In reality, the antenna would be containedwholly within the capsule.

[0043] Capsule 20 is adapted to be ingested, implanted, inserted orotherwise positioned within a mammalian body or tract, to sense pressurewithin the body or tract, and to transmit such sensed pressure in theform of an RF or acoustic signal via antenna 25.

[0044]FIG. 2 shows a variant form of capsule that has multiple sensors.This capsule, generally indicated at 28, is schematically shown ashaving one or more surface pressure sensors 29, an optical ultravioletlight source channel 30, an optical detector, scanner and lenscombination, indicated at 31, a compartment 32 containing opticalscanning electronics, a temperature sensor 33, a pH sensor 34, acompartment 35 containing a microprocessor, a compartment 36 containingsensor signal conditioning electronics, a battery compartment 38, acompartment containing transmitter electronics 39, and an antenna 40which is arranged to broadcast an RF or acoustic signal reflecting thevalues of such sensed parameters. Here again, antenna 40 is depictedschematically.

[0045]FIG. 3 is a schematic view of a medicament dispensing capsule,generally indicated at 41. Capsule 41 is shown as including acompartment 42 containing a medicament or fluid and closed by a door 43,a battery compartment 44, a receiver, and a power switch and sealcompartment 46, and a receiving antenna 48 that is arrange to receive anRF or acoustic signal broadcast from outside the body or tract and tocause the medicament to be dispensed at a desired location within thebody or tract.

[0046]FIG. 4 is a schematic view of a fluid sampling, generallyindicated at 49. Capsule 41 is again shown as including a compartment 42into which a fluid sample may be received and closed by a door 43, abattery compartment 44, a receiver, and a power switch and sealcompartment 46, and a receiving antenna 48 that is arrange to receive anRF or acoustic signal broadcast from outside the body or tract and tocause the medicament to be dispensed at a desired location within thebody or tract.

[0047]FIG. 5 is a schematic view of the receiving apparatus. Basically,the apparatus, generally indicated at 50, contains a plurality ofreceiving antennas, severally indicated at 51 and individuallyidentified by the letters A, B, C and D, an antenna input filter 52, anantenna multiplexer 53, and a dual mixer receiver 54. The output ofreceiver 54 is provided to a phase-locked-loop filter 55, and to amicroprocessor 56. Filter 55 and microprocessor 56 are coupled directlyvia line 58. The output of microprocessor 56 is provided to an RS 232Cinterface, represented by block 59, and then to a 900 MHz wirelessinterface, represented by block 60. The output of microprocessor 56 isalso provided to a flash memory device, represented by block 61. Areal-time clock, represented by block 62, is arranged to provide asignal to microprocessor 56. A built-in test unit, represented by block63, is connected to system power regulators and RF components,communication subsystems and batteries, represented by box 64. Powersequencing circuitry, contained within box 65, is connected to theregulators and batteries, and is also supplies a signal to themicroprocessor via conductor 66. The test unit 63 is connected to theconductor 66 communicating the power sequencing circuitry with themicroprocessor.

[0048] The invention broadly provides an improved method of determiningthe real-time location of the capsule in a mammalian body or tract. Thecapsule may be inserted, ingested, implanted or otherwise positionedinto the tract. The tract may be a gastrointestinal tract, an auditorytract, a respiratory tract, or a reproductive tract. The capsule isarranged to broadcast a radio and/or acoustic signal reflecting thevalues of one or more physiological parameters sensed by the capsule, asindicated above. For example, the patient will swallow a capsule. As thecapsule is advanced along the gastrointestinal tract, the capsule willbroadcast a signal reflective of the parameters sensed along itspassage. These parameters may be sensed continuously or intermittently,as desired. Indeed, the parameters may be sensed and determined on ananalog or digital basis. The capsule then transmits an RF or acousticsignal. The signal is received by the receiving antennas. The receivesignal is then used to determine the real-time location of the capsuleat the time the signal was sent. This does not necessarily mean that thevalue of the sensed parameter must be read or interpreted at the time ofreceipt. Rather, it could be stored for reading or analysis at somelater time.

[0049] Nevertheless, by determining the real-time location of thecapsule, the electronics determine the precise location from which thesignal was sent. The location may be determined in a number of ways. Forexample, the signal may be used to determine the spatial location of thecapsule within the body chest barrel. For example, this could bedetermined in terms in terms of the x, y and z coordinates of thecapsule location.

[0050] Alternatively, or in addition thereto, the location could bedetermined in terms of the position of the capsule within thegastrointestinal tract (i.e., whether in the stomach, the smallintestine, the large intestine, or the like). These various portions ofthe gastrointestinal tract are believed to have various indicatingparameters. For example, the pH of the stomach may be relatively acidic.On the other hand, the pressure within the small intestine may be thedominant parameter. Hence, by sensing a change in the pH and an increasein the pressure, one might infer that the capsule has passed from thestomach into the small intestine. Thus, the capsule may be used tomeasure motility of the capsule as it progresses through the patient'sbody. Knowing the location of the capsule within the gastrointestinaltract when one reading is transmitted, monitoring the progress of same,and knowing the location of the capsule when a subsequent reading istransmitted, one can calculate the speed of propagation or time oftransit of the capsule through the particular section of the tract.

[0051] The location of the capsule may be determined either as afunction of the phase difference between the transmitted and receivedsignals, as a function of the difference in the time between the time oftransmission of the transmitted signal and the time of receipt of thereceived signal, or as a function of differences of signal amplitudereceived at different receivers. In addition, the capsule may betethered to some object. For example, the capsule could be tethered toanother capsule that is ingested or otherwise inserted into the bodytract, or to some object located outside of the tract, or at least theportion of the tract under consideration. The capsule may be operativelyarranged to dispense medicament at a desired location, such as shown anddescribed in U.S. Pat. No. 5,279,607, or may be used to take in a fluidsample at a desired location of the body, such as shown and described inU.S. Pat. No. 5,395,366.

[0052] In one particular unique form, the capsule has multiple sensorsto determine at least three physiological parameters, such as pH,pressure, temperature, transit time, the presence or absence of adisease marker, the presence or absence of a diagnostic marker, anantibody, an antigen, subsurface imaging, conductance and/or anelectrical signal. Some of these sense parameters may be used todetermine a first location and others of the parameters are used todetermine a second location of the capsule. The first and secondlocations may be compared to corroborate the apparent location of thecapsule.

[0053] Thus, the real-time location of the capsule may be determined asthe function of the received signal and a receive value of the sensedparameter.

[0054] Preferably, the capsule is MRI-compatible such that its locationwithin the body can also be determined by means of magnetic residenceimaging, if desired.

[0055] In one form, the capsule may have a fluid storage compartment,and the improved method may include the additional step of dispensingfluid from the compartment into a portion of the tract, and measuringthe volume of the compartment of such portion as a function of theconcentration of the dispensed fluid with the portion. This isparticularly useful in determining the conformance or capacity of astomach.

[0056] If the transmitter is an RF signal, it is presently preferredthat the transmitter broadcast the signal at a frequency in excess ofabout 5 kilohertz, but less than about 10 gigahertz. If the transmittedmedium is an acoustic wave, it is desired that the frequence by inexcess of 100 Hz, but less than about 1.5 MHz.

[0057] The invention is not limited to use within a tract of a mammalianbody. Indeed, the capsule could be implanted or otherwise positioned ina particular organ or cavity of the body, and used to transmit a signalreflecting the value of a sensed parameter from a stationary location.

[0058] If the inventive capsule is used in a gastrointestinal tract, thelocation of the capsule is preferably determined electronically by meansof algorithm-based logic, such as artificial intelligence, a neural net,or a deterministic statistics approach.

[0059] Therefore, while several forms of the improved capsule andreceiver have been shown and described, and various changes andmodifications to the apparatus and method discussed, persons skilled inthis art will readily appreciate that various additional changes andmodifications may be made without departing from the spirit of theinvention, as defined and differentiated by the following claims.

What is claimed is:
 1. The method of determining the real-time locationof a capsule in a tract of a mammal, comprising the steps of: providinga capsule, said capsule having sensors to determine at least twophysiological parameters of said tract, said capsule also having atransmitter operatively arranged to transmit a signal reflecting suchsensed parameters; inserting said capsule into said tract; transmittingsaid signal from said transmitter; receiving said transmitted signalexteriorly of said tract; and determining the real-time location of saidcapsule within said tract as a function of said received signal.
 2. Themethod as set forth in claim 1 wherein said signal is a radio signaland/or an acoustic signal.
 3. The method as set forth in claim 1 whereinsaid tract is one of an auditory, respiratory, reproductive, andgastrointestinal tract.
 4. The method as set forth in claim 3 whereinsaid tract is said gastrointestinal tract, and wherein capsule isingested into said gastrointestinal tract.
 5. The method as set forth inclaim 1 wherein the location of said capsule is determined either as afunction of the phase difference between the transmitted and receivedsignals, as a function of the difference in time between the time oftransmission of said transmitted signal and the time of receipt of saidreceived signal, or as a function of received signals at multiplelocations.
 6. The method as set forth in claim 1, and further comprisingthe additional step of: determining the value of at least one of saidsensed parameters exteriorly of said tract as a function of saidreceived signal.
 7. The method as set forth in claim 1 wherein thereal-time location of said capsule within said tract is determined as afunction of the strength of said received signal and such received valueof at least one of said sensed parameters.
 8. The method as set forth inclaim 1 and further comprising the additional step of: tethering saidcapsule to an object.
 9. The method as set forth in claim 8 wherein saidobject is another capsule that is inserted into said tract.
 10. Themethod as set forth in claim 8 wherein said object is located outsidethe body.
 11. The method as set forth in claim 1 wherein said capsulehas a storage compartment containing medicament, and further comprisingthe additional step of: dispensing medicament from said compartment at adesired location within said tract.
 12. The method as set forth in claim1 wherein said capsule has a fluid storage compartment, and furthercomprising the additional step of: taking in a fluid sample to saidcompartment at a desired location within said tract.
 13. The method asset forth in claim 12 wherein at least one of said sensors is arrangedwithin said fluid storage compartment.
 14. The method as set forth inclaim 1 wherein said capsule has sensors to determine at least two ofsaid physiological parameters, wherein some of said sensed parametersare used to determine a first location of said capsule, wherein othersof said sensed parameters are used to determine a second location ofsaid capsule, and wherein said first and second locations are comparedto corroborate the location of said capsule.
 15. The method as set forthin claim 1 wherein at least one of said physiological parameters areselected from the group consisting of: pH, pressure, temperature,transit time, a disease marker, a diagnostic marker, an antibody, anantigen, subsurface imaging, conductance, and an electrical signal. 16.The method of determining the real-time location of a capsule in a tractof a mammal, comprising the steps of: providing a capsule, said capsulehaving at least one sensor operatively arranged to determine aphysiological parameter of said tract, said capsule also having atransmitter; inserting said capsule into said tract; transmitting fromsaid transmitter a signal reflective of the value said sensed parameter;receiving said transmitted signal exteriorly of said tract; anddetermining the real-time location of said capsule within said tract asa function of said received signal and the received value of said sensedparameter.
 17. The method as set forth in claim 16 wherein said signalis a radio signal and/or an acoustic signal.
 18. The method as set forthin claim 16 wherein said tract is one of an auditory, respiratory,reproductive and a gastrointestinal tract.
 19. The method as set forthin claim 18 wherein said tract is said gastrointestinal tract, andwherein said capsule is ingested into said gastrointestinal tract. 20.The method as set forth in claim 16 wherein the location of said capsuleis determined either as a function of the phase difference between thetransmitted and received signals, as a function of the difference intime between the time of transmission of said transmitted signal and thetime of receipt of said received signal, or amplitude of receivedsignals from multiple receivers.
 21. The method as set forth in claim16, and further comprising the additional step of: determining the valueof said sensed parameter exteriorly of said tract as a function of saidreceived signal.
 22. The method as set forth in claim 16 wherein thereal-time location of said capsule within said tract is determined as afunction of the strength of said received signal and such received valueof said sensed parameter.
 23. The method as set forth in claim 16 andfurther comprising the additional step of: tethering said capsule to anobject.
 24. The method as set forth in claim 23 wherein said object isanother capsule that is inserted into said tract.
 25. The method as setforth in claim 23 wherein said object is located outside the body. 26.The method as set forth in claim 16 wherein said capsule has a storagecompartment containing medicament, and further comprising the additionalstep of: dispensing medicament from said compartment at a desiredlocation within said tract
 27. The method as set forth in claim 16wherein said capsule has a fluid storage compartment, and furthercomprising the additional step of: taking in a fluid sample to saidcompartment at a desired location within said tract.
 28. The method asset forth in claim 27 wherein at least one of said sensors is arrangedwithin said fluid storage compartment.
 29. The method as set forth inclaim 16 wherein said capsule has sensors to determine at least two ofsaid physiological parameters, wherein some of said sensed parametersare used to determine a first location of said capsule, wherein othersof said sensed parameters are used to determine a second location ofsaid capsule, and wherein said first and second locations are comparedto corroborate the location of said capsule.
 30. The method as set forthin claim 16 wherein at least one of said physiological parameters areselected from the group consisting of: pH, pressure, temperature,transit time, a disease marker, a diagnostic marker, an antibody, anantigen, subsurface imaging, conductance, and an electrical signal. 31.The method of determining the value of a physiological parameter in atract of a mammal, comprising the steps of: providing an MRI-compatiblecapsule, said capsule having a sensor operatively arranged to determineat least one physiological parameter of said tract, said capsule alsohaving a transmitter operatively arranged to transmit a signalreflecting such sensed parameter; inserting said capsule into saidtract; tethering said capsule to an object; transmitting said signalfrom said transmitter; receiving said transmitted signal exteriorly ofsaid tract; and determining the value of said sensed parameter as afunction of said received signal.
 32. The method as set forth in claim31 wherein said signal is a radio signal and/or an acoustic signal. 33.The method as set forth in claim 31 wherein said tract is one of anauditory, respiratory, reproductive and a gastrointestinal tract. 34.The method as set forth in claim 33 wherein said tract is saidgastrointestinal tract, and wherein said capsule is ingested into saidgastrointestinal tract.
 35. The method as set forth in claim 31 whereinthe location of said capsule is determined as a function of the phasedifference between the transmitted and received signals, as a functionof the difference in time between the time of transmission of saidtransmitted signal and the time of receipt of said received signal, oras a function of the amplitude of received signals from multiplereceivers.
 36. The method as set forth in claim 31, and furthercomprising the additional step of: determining the value of at least oneof said sensed parameters exteriorly of said tract as a function of saidreceived signal.
 37. The method as set forth in claim 31 wherein thereal-time location of said capsule within said tract is determined as afunction of the strength of said received signal and such received valueof at least one of said sensed parameters.
 38. The method as set forthin claim 31 and further comprising the additional step of: tetheringsaid capsule to an object.
 39. The method as set forth in claim 38wherein said object is another capsule that is inserted into said tract.40. The method as set forth in claim 38 wherein said object is locatedoutside the body.
 41. The method as set forth in claim 31 wherein saidcapsule has a storage compartment containing medicament, and furthercomprising the additional step of: dispensing medicament fromsaid-compartment at a desired location within said tract.
 42. The methodas set forth in claim 31 wherein said capsule has a fluid storagecompartment, and further comprising the additional step of: taking in afluid sample to said compartment at a desired location within saidtract.
 43. The method as set forth in claim 42 wherein at least one ofsaid sensors is arranged within said fluid storage compartment.
 44. Themethod as set forth in claim 31 wherein said capsule has sensors todetermine at least three of said physiological parameters, wherein someof said sensed parameters are used to determine a first location of saidcapsule, wherein others of said sensed parameters are used to determinea second location of said capsule, and wherein said first and secondlocations are compared to corroborate the location of said capsule. 45.The method as set forth in claim 31 wherein at least one of saidphysiological parameters are selected from the group consisting of: pH,pressure, temperature, transit time, a disease marker, a diagnosticmarker, an antibody, an antigen, subsurface imaging, conductance, and anelectrical signal.
 46. The method of determining the real-time locationof a capsule in a tract of a mammal, comprising the steps of: providinga capsule, said capsule also having a transmitter operatively arrangedto transmit an RF signal at a frequency in excess of about 5 kilohertz;inserting said capsule into said tract; transmitting said signal fromsaid transmitter; receiving said transmitted signal exteriorly of saidtract; and determining the real-time location of said capsule withinsaid tract as a function of said received signal.
 47. The method as setforth in claim 46 wherein said transmitter is operatively arranged totransmit a signal a frequency of less that about 10 gigahertz.
 48. Themethod of determining the real-time location of a capsule in a tract ofa mammal, comprising the steps of: providing a capsule, said capsulealso having a transmitter operatively arranged to transmit an acousticsignal at a frequency in excess of about 100 hertz; inserting saidcapsule into said tract; transmitting said signal from said transmitter;receiving said transmitted signal exteriorly of said tract; anddetermining the real-time location of said capsule within said tract asa function of said received signal.
 49. The method as set forth in claim48 wherein said transmitter is operatively arranged to transmit a signala frequency of less that about 1.5 megahertz.
 50. The method ofdetermining the real-time location of a capsule in a tract of a mammal,comprising the steps of: providing a capsule, said capsule having atransmitter operatively arranged to transmit a signal; inserting saidcapsule into said tract; providing a plurality of receivers exteriorlyof said tract; transmitting said signal from said transmitter; receivingsaid transmitted signal on said receivers; and determining the real-timelocation of said capsule as a function of the signals received by saidreceivers.
 51. The method as set forth in claim 50 wherein said capsulehas at least one sensor operatively arranged to determine at least onephysiological parameter within said tract, and wherein said transmitteris arranged to generate a signal reflective of such sensed parameter.52. The method as set forth in claim 50 wherein said real-time locationis determined using algorithm-based logic.
 53. The method as set forthin claim 52 wherein said logic uses artificial intelligence.
 54. Themethod as set forth in claim 53 wherein said artificial logic uses aneural net.
 55. The method as set forth in claim 53 wherein said logicuses a deterministic statistic approach.
 56. The method of determiningthe value of a parameter in a mammal body, comprising the steps of:providing a capsule, said capsule having a sensor to determine aphysiological parameter of said body and having a transmitteroperatively arranged to transmit a signal; inserting said capsule intosaid body; providing a receiver exteriorly of said body; transmittingsaid signal from said transmitter; receiving said transmitted signal onsaid receiver; and determining the value of said physiological parameterexteriorly of said body as a function of the signals received by saidreceiver.
 57. The method as set forth in claim 56 wherein the locationof said capsule is stationary within said body.